Contact information
Type
Scientific
Primary contact
Dr Kate Jolly
ORCID ID
Contact details
Unit of Public Health
Epidemiology and Biostatistics
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7552
c.b.jolly@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 4
Study information
Scientific title
Evaluation of weight reduction programmes in the "Lighten Up" service in South Birmingham primary care trust (PCT): a randomised controlled trial
Acronym
Lighten Up
Study hypothesis
The weight loss programmes (Weight Watchers®, Slimming World, Rosemary Conley, NHS Size Down, pharmacy and general practice provision) will each achieve significantly greater weight loss at 3 months follow-up than the comparison group of exercise at a leisure centre. There will be no differences between the weight loss services in weight loss at 3 months.
Ethics approval
South Birmingham Research Ethics Committee, approved on 19/12/2008 (ref: 08/H1207/331)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obesity
Intervention
Participants will be allocated to one of the following eight arms:
1. Commercial weight loss programme: Weight Watchers
2. Commercial weight loss programme: Slimming World
3. Commercial weight loss programme: Rosemary Conley
4. Size Down (NHS community-based group programme)
5. Pharmacy-led obesity services
6. General practice service
7. Choice of intervention (1 to 6 above)
8. Comparator: Exercise advice + membership to leisure centre (Participants in this group will not be provided with any specific exercise programme)
Total duration of interventions: 12 weeks
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Weight at 3 months follow-up
Secondary outcome measures
1. Weight loss at 1 year
2. Self-reported physical activity using the International Physical Activity Questionnaire-Short version (IPAQ-Short) at 3 and 12 months
3. Percentage weight loss at 3 months and 1 year
Overall trial start date
26/01/2009
Overall trial end date
03/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged at least 18 years, both males and females
2. Body mass index greater than or equal to 30 (based on data recorded via NHS Quality and Outcomes Framework [QoF])
3. Identified by GP as medically competent to enter the programme evaluation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
740
Participant exclusion criteria
1. Unable to understand English
2. Women who are known to be pregnant
3. Not willing to be randomised
Recruitment start date
26/01/2009
Recruitment end date
03/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Unit of Public Health, Epidemiology and Biostatistics
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
NHS South Birmingham (UK)
Sponsor details
c/o Dr Jim O'Brien
Head of Clinical Governance
8th Floor
Triplex House
Eckersall Road
Kings Norton
Birmingham
B38 8SS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS South Birmingham (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22053315
Publication citations
-
Results
Jolly K, Lewis A, Beach J, Denley J, Adab P, Deeks JJ, Daley A, Aveyard P, Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial., BMJ, 2011, 343, d6500.